Manager, Pharmacovigilance Operations

8+ years

Not Disclosed

Hyderabad Mohali

12 May 21, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Manager, PV Operations

Job Purpose:

The Manager, PV Operations oversees and supervises the day-to-day activities of the project's PV Operations staff. They ensure the quality of deliverables, adherence to timelines, and relevant training compliance. Additionally, they provide process-related expertise for various project-specific activities, including processing Individual Case Safety Reports, Signal and risk management, Regulatory operations, and Medical writing. The Manager ensures compliance with regulations and Standard Operating Procedures (SOPs) and communicates with clients for queries/feedback.

Skills:

Leadership: Excellent leadership and line management skills.
Drug Safety Knowledge: Profound understanding of drug safety and the drug development process.
Regulatory Compliance: Strong knowledge of global safety regulations and the ability to interpret and apply them.
Data Analysis: Experience in data analysis, evaluation of safety data, and preparation of safety reports.
Team Management: Exceptional team/project leadership, delegation, training, and mentoring skills.
Communication: Outstanding presentation, interpersonal, verbal, and written communication skills.
Time Management: Excellent time management skills.
Client Focus: Client-focused approach to work.
Technical Skills: Experience with computer applications including database management and Pharmacovigilance related computing systems.

Knowledge and Experience:

Considerable drug safety knowledge and experience.
Minimum 8 years of experience in pharmacovigilance/drug safety or allied fields and people management.

Parexel employs over 16,000 professionals, with offices supporting clients in over 100 countries worldwide. We offer the most comprehensive drug development capabilities of any CRO globally, integrating global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services to support clients through the development journey efficiently and cost-effectively.

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Manager, Pharmacovigilance Operations

Job Description

Job Title: Manager, PV Operations

Job Purpose:

Skills:

Knowledge and Experience:

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